PFT CALIBRATOR— 510(k) K801597

Substantially Equivalent

Spital Medical, Inc.

FDA 510(k) clearance K801597 for PFT CALIBRATOR, Substantially Equivalent on 1980-08-04. Applicant: Spital Medical, Inc.. Device class: 2.

Clearance details

Applicant: Spital Medical, Inc.
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 1980-06-24
Decision date: 1980-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.